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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-37/
- Published: 2020-09-15T12:00:00.000Z
- Updated: 2026-09-14T16:28:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147658

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

**Kalchem International**, Lindsay, OK (8/27): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). For example, Kalchem failed to have, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. The firm’s quality unit also failed to exercise its responsibility to ensure the APIs manufactured at the facility comply with GMPs. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kalchem-international-inc-607098-08272020?ref=fdaweb.com).

**Mayon’s Pharmaceuticals**, Maharashtra, India (9/4): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Mayon’s failed to establish written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess. It also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mayons-pharmaceuticals-pvt-ltd-607388-09042020?ref=fdaweb.com).

**Silkprousa**, Miami, FL (8/18): FDA says the firm is marketing its Pink Luminous Breast, a Class 3 transilluminator for breast evaluation, without marketing approval. The agency says the determination was based on the labeling on the package, statements on the company’s Web site and how the device functions, such as visualizing translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities. The device was also found to be misbranded because labeling on the product’s package and Web site uses FDA’s logo. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silkprousa-llc-608493-08182020?ref=fdaweb.com).