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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-36/
- Published: 2020-09-08T12:00:00.000Z
- Updated: 2026-09-14T16:27:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147605

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.  
  
**PT MegaSurya Mas**, Indonesia (8/24): FDA inspected the firm 11/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have, for each batch of a drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for its drug product, including the identity and strength of each active ingredient, before release, and failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods. Additionally, it failed to follow written procedures for production and process controls designed to assure that its drug products 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/pt-megasurya-mas-604366-08242020?ref=fdaweb.com).

**Calvin Scott and Co.**, Albuquerque, NM (8/25): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to assure that its drug products bore an expiration date that was supported by appropriate stability testing. It also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/calvin-scott-company-inc-606987-08252020?ref=fdaweb.com).