# FDA WARNING_LETTER - Bershtel Enterprises LLC dba WePackItAll - November 01, 2018

Source: https://www.globalkeysolutions.net/records/warning_letter/bershtel-enterprises-llc-dba-wepackitall/9fce9444-9fe3-4f06-a56c-67d0ccf26512

> FDA WARNING_LETTER for Bershtel Enterprises LLC dba WePackItAll on November 01, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bershtel Enterprises LLC dba WePackItAll
- Inspection Date: 2018-11-01
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Bershtel Enterprises LLC dba WePackItAll from October 15 to November 1, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to prevent microbiological contamination and validate sterile processes (21 CFR 211.113(b) & 211.42(c)(10)):** The firm manufactured a multi-dose, preservative-free, homeopathic ophthalmic drug product without adequate sterility controls. The filling suite was unsuitable for sterile drugs, lacking proper surfaces, HEPA-filtered air, environmental monitoring, cleaning systems, and equipment maintenance for aseptic conditions. The firm also lacked sterilization procedures and admitted to not being equipped for sterile drug production, even using a "waiver" for non-sterile filling. FDA lab analysis confirmed contamination with *Bacillus spp.* and particulate matter, leading to a product recall. The firm's response was inadequate, failing to acknowledge its CGMP responsibility and provide plans for screening drug products.
2.  **Failure to investigate discrepancies (21 CFR 211.192):** The firm released ophthalmic drug product despite visible contaminants ("white specs") without a thorough root cause investigation, relying on an inadequate assumption that limited testing assured safety. The firm also lacked a comprehensive system for investigating deviations, OOS results, and complaints.
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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/bershtel-enterprises-llc-dba-wepackitall/e8099d86-190b-40de-b0a6-b00b391ccad8

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6