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Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

FDA import alert and refusal historyTlajomulco De Zuniga, MexicoFEI 3007502289

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As of October 26, 2026, Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) (Tlajomulco De Zuniga, Mexico) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for electrolit pineapple flavored rehydrating beverage, published by FDA on March 30, 2023, is also listed on Import Alert 99-39 (red list), and has 414 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
IA 45-02 · red listIA 99-39 · red list
Last import refusal
Oral rehydration products · INCONSPICU
Last warning letter
None found
Last inspection
None on record

Every FDA record for Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

The 300 most recent of 416 records, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, 2 lines in one entry: Oral rehydration productsINCONSPICUEntry BJG-0217869-6Show 2 lines
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Oral rehydration productsLIST INGREINCONSPICUFALSENO ENGLISHEntry BJG-0216869-7Show 2 lines
    Source
  3. Import refusal
    Refused, 2 lines in one entry: Oral rehydration productsLIST INGREINCONSPICUFALSENO ENGLISHEntry BJG-0216901-8Show 2 lines
    Source
  4. Import refusal
    Refused, Oral rehydration productsLIST INGREINCONSPICUFALSENO ENGLISHLABELINGNUTRIT LBLUNAPPROVEDEntry BJG-0217319-2
    Source
  5. Import refusal
    Refused, 3 lines in one entry: Oral rehydration productsINCONSPICUEntry BJG-0217261-6Show 3 lines
    Source

2025

  1. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLEntry NDA-0006987-8
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Noncarbonated soft drink, n.e.c.; Bottled water with fruit flavors, noncarbonated (nonmedicinal)INCONSPICUUNAPPROVEDEntry BJG-0200290-4Show 2 lines
    Source
  3. Import refusal
    Refused, Oral rehydration productsINCONSPICUFALSENUTRIT LBLUNAPPROVEDEntry BJG-0200807-5
    Source
  4. Import refusal
    Refused, Oral rehydration productsNO ENGLISHUNAPPROVEDEntry BJG-0169227-5
    Source
  5. Import refusal
    Refused, Oral rehydration productsNO ENGLISHUNAPPROVEDEntry BJG-0195979-9
    Source
  6. Import refusal
    Refused, 5 lines in one entry: Oral rehydration productsUNSAFE ADDINCONSPICUFALSENUTRIT LBLEntry 9UG-0142559-0Show 5 lines
    Source
  7. Import refusal
    Refused, 9 lines in one entry: Oral rehydration productsNO ENGLISHUNAPPROVEDEntry BJG-0191095-8Show 9 lines
    Source
  8. Import refusal
    Refused, 5 lines in one entry: Oral rehydration productsINCONSPICUFALSENUTRIT LBLUNAPPROVEDEntry BJG-0189665-2Show 5 lines
    Source
  9. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsFALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0190078-5Show 8 lines
    Source
  10. Import refusal
    Refused, 6 lines in one entry: Oral rehydration productsINCONSPICUFALSENUTRIT LBLUNAPPROVEDEntry BJG-0189104-2Show 6 lines
    Source
Show 251 earlier records (2022–2025)

2025

  1. Import refusal
    Refused, 7 lines in one entry: Oral rehydration productsUNSAFE ADDINCONSPICUUNSAFE COLEntry 8DD-0000653-6Show 7 lines
    Source

2024

  1. Import refusal
    Refused, 10 lines in one entry: Oral rehydration productsUNAPPROVEDNO ENGLISHUNSAFE COLCOLOR LBLGEntry BJG-0169376-0Show 10 lines
    Source
  2. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsUNSAFE ADDINCONSPICUFALSENUTRIT LBLEntry NDS-3100055-2Show 8 lines
    Source
  3. Import refusal
    Refused, Oral rehydration productsUNSAFE ADDINCONSPICUFALSENUTRIT LBLUNAPPROVEDEntry 9UG-0128680-2
    Source
  4. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsLIST INGREUNSAFE ADDFALSELACKS N/CEntry NDS-3100042-0Show 8 lines
    Source
  5. Import refusal
    Refused, 6 lines in one entry: Oral rehydration productsNO ENGLISHUNAPPROVEDUNSAFE COLCOLOR LBLGEntry BJG-0166719-4Show 6 lines
    Source
  6. Import refusal
    Refused, 6 lines in one entry: Oral rehydration productsLIST INGREINCONSPICUNUTRIT LBLEntry BJG-0163108-3Show 6 lines
    Source

2023

  1. Import refusal
    Refused, Oral rehydration productsLIST INGREFALSEEntry BJG-0155941-7
    Source
  2. Import refusal
    Refused, Oral rehydration productsUNSAFE COLCOLOR LBLGEntry BJG-0161612-6
    Source
  3. Import refusal
    Refused, 4 lines in one entry: Oral rehydration productsFALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry NDS-3003764-7Show 4 lines
    Source
  4. Import refusal
    Refused, 5 lines in one entry: Oral rehydration productsLIST INGRENO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0158749-1Show 5 lines
    Source
  5. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry NDA-0002621-7Show 2 lines
    Source
  6. Import refusal
    Refused, 7 lines in one entry: Oral rehydration productsUNAPPROVEDINCONSPICUFALSENO ENGLISHEntry 9LN-2042958-5Show 7 lines
    Source
  7. Import refusal
    Refused, Oral rehydration productsUNAPPROVEDEntry 9LN-2043069-0
    Source
  8. Import refusal
    Refused, Oral rehydration productsNO ENGLISHUNAPPROVEDEntry BJG-0156202-3
    Source
  9. Import refusal
    Refused, Oral rehydration productsFALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0155551-4
    Source
  10. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsFALSELACKS N/CNO ENGLISHUNAPPROVEDEntry NDS-3003174-9Show 8 lines
    Source
  11. Import refusal
    Refused, Oral rehydration productsNO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0155750-2
    Source
  12. Import refusal
    Refused, Oral rehydration productsLIST INGREINCONSPICUFALSENO ENGLISHLABELINGNUTRIT LBLUNAPPROVEDEntry BJG-0155515-9
    Source
  13. Import refusal
    Refused, 2 lines in one entry: Oral rehydration productsNO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0155750-2Show 2 lines
    Source
  14. Import refusal
    Refused, Oral rehydration productsLIST INGREINCONSPICUFALSENO ENGLISHLABELINGNUTRIT LBLUNAPPROVEDEntry BJG-0155515-9
    Source
  15. Import refusal
    Refused, 6 lines in one entry: Oral rehydration productsNO ENGLISHNUTRIT LBLUNAPPROVEDEntry BJG-0155750-2Show 6 lines
    Source
  16. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsINCONSPICUNUTRIT LBLUNAPPROVEDEntry BJG-0153334-7Show 8 lines
    Source
  17. Import refusal
    Refused, 9 lines in one entry: Oral rehydration productsINCONSPICUFALSEUNAPPROVEDEntry NDS-3002765-5Show 9 lines
    Source
  18. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  19. Import refusal
    Refused, 4 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 4 lines
    Source
  20. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7Show 2 lines
    Source
  21. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007476-3
    Source
  22. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  23. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 2 lines
    Source
  24. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  25. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 2 lines
    Source
  26. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  27. Import refusal
    Refused, 4 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 4 lines
    Source
  28. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  29. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007476-3
    Source
  30. Import refusal
    Refused, Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7
    Source
  31. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 2 lines
    Source
  32. Import refusal
    Refused, 2 lines in one entry: Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry N9H-0007511-7Show 2 lines
    Source
  33. Import refusal
    Refused, 3 lines in one entry: Nonalcoholic beverages, n.e.c.LIST INGREINCONSPICUFALSENO ENGLISHEntry N9H-0007476-3Show 3 lines
    Source
  34. Import refusal
    Refused, 7 lines in one entry: Oral rehydration productsINCONSPICUUNSAFE ADDEntry BJG-0153465-9Show 7 lines
    Source
  35. Import refusal
    Refused, Oral rehydration productsUNSAFE COLCOLOR LBLGEntry BJG-0148815-3
    Source
  36. Import refusal
    Refused, 4 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry 9UG-0121181-8Show 4 lines
    Source
  37. Import refusal
    Refused, 4 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.LIST INGRENO ENGLISHLABELINGNUTRIT LBLEntry M92-5102865-7Show 4 lines
    Source
  38. Import refusal
    Refused, 3 lines in one entry: Oral rehydration productsINCONSPICUFLAVR LBLGUSUAL NAMENUTRIT LBLEntry BJG-0142893-6Show 3 lines
    Source
  39. Import refusal
    Refused, 10 lines in one entry: Nonalcoholic beverages, n.e.c.FALSENO ENGLISHNUTRIT LBLUNAPPROVEDEntry NDS-3002023-9Show 10 lines
    Source
  40. Import refusal
    Refused, 9 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.INCONSPICUUSUAL NAMELABELINGUNAPPROVEDEntry 9UG-0119750-4Show 9 lines
    Source
  41. Import refusal
    Refused, 8 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.LIST INGREINCONSPICUFALSELACKS N/CEntry 9UG-0119577-1Show 8 lines
    Source
  42. Import refusal
    Refused, 10 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.LIST INGREINCONSPICUFALSELACKS N/CEntry 9UG-0118926-1Show 10 lines
    Source
  43. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsINCONSPICUUSUAL NAMELABELINGUNAPPROVEDEntry 9VA-0294430-3Show 8 lines
    Source
  44. Import refusal
    Refused, 8 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.LIST INGREFALSELACKS N/CNO ENGLISHEntry 9UG-0118778-6Show 8 lines
    Source
  45. Import refusal
    Refused, 11 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.LIST INGREINCONSPICUFALSELACKS N/CEntry 9UG-0118835-4Show 11 lines
    Source
  46. Import refusal
    Refused, 10 lines in one entry: Noncarbonated water (nonmedicinal), n.e.c.NO ENGLISHUSUAL NAMELABELINGUNAPPROVEDEntry 9UG-0119005-3Show 10 lines
    Source
  47. Import alert listing
    Listed on Import Alert 45-02red listElectrolit pineapple flavored rehydrating beverage
    Source
  48. Import refusal
    Refused, Oral rehydration productsUNSAFE COLCOLOR LBLGEntry BJG-0143284-7
    Source
  49. Import refusal
    Refused, Oral rehydration productsNO ENGLISHNUTRIT LBLUNAPPROVEDEntry CCH-0050938-3
    Source

2022

  1. Import refusal
    Refused, 5 lines in one entry: Nonalcoholic beverages, n.e.c.FLAVR LBLGFALSELACKS N/CNO ENGLISHEntry NMH-0021371-9Show 5 lines
    Source
  2. Import refusal
    Refused, Oral rehydration productsUNAPPROVEDEntry 9UG-0108743-2
    Source
  3. Import refusal
    Refused, Oral rehydration productsNO ENGLISHUNAPPROVEDEntry BJG-0131362-5
    Source
  4. Import refusal
    Refused, 8 lines in one entry: Oral rehydration productsINCONSPICUNO ENGLISHUNAPPROVEDLIST INGREEntry BJG-0133160-1Show 8 lines
    Source
  5. Import refusal
    Refused, 6 lines in one entry: Dietary conventional foods, n.e.c.NO ENGLISHUNAPPROVEDEntry BJG-0130197-6Show 6 lines
    Source

Refusal charges, in plain English

  • UNAPPROVED357 refused lines

    Unapproved new drug

    The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

  • NO ENGLISH232 refused lines

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • NUTRIT LBL225 refused lines

    Nutrition information missing from label

    The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

  • FALSE166 refused lines

    False or misleading labeling

    The labeling appeared to be false or misleading in some particular.

  • INCONSPICU166 refused lines

    Required information not conspicuous

    Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

  • LIST INGRE122 refused lines

    Ingredients not listed

    The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

  • LACKS N/C83 refused lines

    Net quantity statement missing

    The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

  • USUAL NAME64 refused lines

    Common or usual name missing

    The label appeared not to show the common or usual name of the food.

Questions about Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

Is Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) on an FDA import alert?
Yes. As of October 26, 2026, Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for electrolit pineapple flavored rehydrating beverage; FDA published the listing on March 30, 2023.
Has FDA refused shipments from Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)?
Yes. FDA refused 414 shipment lines from Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) between August 17, 2022 and September 14, 2026. The most recent, on September 14, 2026, was oral rehydration products, charged as INCONSPICU (required information not conspicuous).
Why did FDA refuse Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)'s shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 357 lines) and NO ENGLISH (required label information not in english, 232 lines).
What is Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)'s FEI number?
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)'s FDA Establishment Identifier (FEI) is 3007502289.
Can shipments from Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) still enter the U.S.?
Shipments of electrolit pineapple flavored rehydrating beverage from Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) can be detained without physical examination under Import Alert 45-02; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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