# FDA WARNING_LETTER - Alchymars ICM SM Private Limited - September 15, 2017

Source: https://www.keypedia.com/records/warning_letter/alchymars-icm-sm-private-limited/bcc492fc-da9a-46d3-815b-2352c09879d1

> FDA WARNING_LETTER for Alchymars ICM SM Private Limited on September 15, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alchymars ICM SM Private Limited
- Inspection Date: 2017-09-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Alchymars ICM SM Private Limited following a September 11-15, 2017, inspection of their Tamil Nadu, India, drug manufacturing facility, identifying significant CGMP deviations for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include:
1. **Falsification of laboratory data:** Discrepancies in CFU counts for water point-of-use tests and observed growth on selective media despite reported absence, particularly concerning for API used in sterile injectable forms.
2. **Inadequate equipment maintenance:** Damaged product-contact surfaces (e.g., deteriorating gaskets) on multi-product equipment, with a lack of gasket replacement records, a repeat observation from a 2015 inspection.
3. **Insufficient quality unit investigations:** Failure to thoroughly investigate customer complaints regarding black spots and out-of-specification moisture content in API, without detailed record reviews.
4. **Poor facility maintenance:** Filthy equipment washroom with damaged tiles and standing water, and visibly dirty handwashing stations in cleanroom areas.
5. **Inadequate personnel facilities:** Inconveniently located and non-functional handwashing stations lacking hot water, soap, or hand drying equipment, also a repeat observation.

The FDA deemed the company's responses inadequate and strongly recommended engaging a qualified CGMP consultant to address systemic issues, particularly data integrity, laboratory controls, investigations, maintenance, and quality oversight

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/alchymars-icm-sm-private-limited/e545dac9-72db-4c33-8111-32531c53be5d

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c