Lnk International Inc.

30 FDA enforcement records linked to this company.

• 4832025-10-28

  Investigations of discrepancies, failures

• 4832025-10-28

  Scientifically sound laboratory controls

• 4832025-10-28

  Cleaning / Sanitizing / Maintenance

• recall — Class II2024-12-18

  CGMP Deviations: Released product should have been rejected.

• recall — Class III2022-10-26

  Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

• recall — Class III2022-09-07

  Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

• recall — Class III2021-07-28

  Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

• 4832021-07-01

  Procedures to be written and followed

• 4832021-07-01

  Cleaning / Sanitizing / Maintenance

• 4832021-07-01

  Procedures not in writing, fully followed

• 4832021-07-01

  Training--operations, GMPs, written procedures

• 4832021-07-01

  Scientifically sound laboratory controls

• warning_letter2019-09-26

  FDA Warning Letter (drug product)

• recall — Class II2019-08-07

  Microbial contamination of non-sterile product

• 4832019-02-08

  Written record of complaint to include findings, follow-up