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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-23/
- Published: 2020-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:15:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146819

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Blaine Labs**, Santa Fe Springs, CA (5/5): FDA inspected the firm 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company also failed to establish adequate written procedures for production and process controls designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blaine-labs-inc-598733-05052020?ref=fdaweb.com).

**Lymol Medical**, Woburn, MA (4/7): FDA inspected the company in February and cited GMP deficiencies with its Elite X Class Rigid Bronchoscope System and Premier S Class Silicone Stents. For example, Lymol failed to validate the manual cleaning processes, sterilization processes, and storage conditions for its devices. The company also failed to establish and maintain procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before implantation. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lymol-medical-corporation-606833-04072020?ref=fdaweb.com).

**International Trading Pharm Lab**, Paterson, NJ (4/24): FDA inspected the firm and cited GMP deficiencies for active pharmaceutical ingredients (API). For example, the firm’s quality unit failed to ensure that drugs are appropriately tested and the results are reported. Additionally, it failed to establish and follow written procedures for investigating critical deviations or the failure of API batches to meet specifications. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-trading-pharm-lab-inc-598537-04242020?ref=fdaweb.com).