# FDA WARNING_LETTER - Compound Preferred LLC - March 01, 2017

Source: https://www.keypedia.com/records/warning_letter/compound-preferred-llc/d7d4a707-3d72-4915-bda4-bc79715216e7

> FDA WARNING_LETTER for Compound Preferred LLC on March 01, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Compound Preferred LLC
- Inspection Date: 2017-03-01
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: On October 27, 2017, the FDA issued a Warning Letter to RAM Pharma, Inc., an outsourcing facility registered under section 503B of the FDCA. An inspection from February 7 to March 1, 2017, revealed serious deficiencies in sterile drug production and failure to meet 503B conditions, rendering products adulterated and misbranded.

Violations included:
- **Failure to meet 503B conditions:** Drug labels lacked required statements (e.g., "This is a compounded drug," quantity/volume, adverse event reporting info, ingredient lists). The facility also failed to submit initial and complete drug product reports in July and December 2016.
- **Adulterated Drug Products (Insanitary Conditions):** The ISO-5 hood was constructed of unfinished particle board, 19 lots of sterile products were released from an uncertified ISO-5 hood, an industrial vacuum was used in the ISO-7 clean room before production, media fills were not conducted, and non-sterile wipes were used in the ISO-5 hood.
- **Adulterated Drug Products (CGMP Violations):** Failures included maintaining aseptic equipment, establishing procedures to prevent microbiological contamination, cleaning/disinfecting rooms/equipment, testing for final specifications (sterility/endotoxins), ensuring appropriate personnel gowning, and establishing stability testing programs.
- **Misbranded Drug

## Related Documents

- [483 - 2017-03-01](https://www.keypedia.com/records/483/compound-preferred-llc/2cb56dff-6dd8-4e94-9589-fdc271871fa9)
- [483_RESPONSE - 2017-03-01](https://www.keypedia.com/records/483_response/compound-preferred-llc/0913ec67-3f8d-46ce-96f1-8444c3be3e62)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/compound-preferred-llc/5d40fe4e-e577-4b81-9059-578d4c7cd1a3)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/compound-preferred-llc/8b6d495f-8b79-495b-8ade-3ca5e95ce9a6)
- [483 - 2021-12-17](https://www.keypedia.com/records/483/compound-preferred-llc/6e16267f-c12e-46a1-87a5-454c861549fe)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/compound-preferred-llc/0137c1b7-e3ba-45ff-9fda-c53b21b0b857

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b