# FDA 483 - JCB Laboratories LLC - December 03, 2015

Source: https://www.globalkeysolutions.net/records/483/jcb-laboratories-llc/a108e16b-8016-4d2a-8001-ed0e040da318

> FDA 483 for JCB Laboratories LLC on December 03, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JCB Laboratories LLC
- Inspection Date: 2015-12-03
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies at an outsourcing facility manufacturing pharmaceutical products.

**Laboratory Controls and Testing:**
*   The facility lacks validated strength testing methods for all finished pharmaceutical products, despite manufacturing various types. This impacts the final release of products.

**Master Production and Control Records:**
*   **Betamethasone Sodium Phosphate Injectable 6 mg/ml solution:** Batch records are incomplete, not specifying if a specific tool can be used in a step, not recording the amount of a substance, and not following a procedure regarding vial handling (procedure says "vials," but they "the vials"). Check fill volumes are not recorded prior to aseptic filling.
*   **Lidocaine Jelly (multi-API product):** Batch records lack detailed mixing instructions (e.g., no time requirement or instructions on how to "mix"). Check fill volumes are not recorded prior to filling. This product has 5 batches with documented sub-potency issues (DEV-2015-122, -123, -306).

**Failure Investigation:**
*   A thorough review of batch failures is lacking. For DEV-2015-306 (sub-potent Lidocaine Jelly batch), no CAPA was planned beyond monitoring trends. "Potential human error" was cited without justification. The investigation failed to identify or discuss unvalidated manufacturing/strength testing methods, identify a root cause, or initiate a CAP

## Related Documents

- [WARNING_LETTER - 2013-02-27](https://www.globalkeysolutions.net/records/warning_letter/jcb-laboratories-llc/c771bb90-ed68-4631-832e-65560d12f8c0)
- [483 - 2013-02-27](https://www.globalkeysolutions.net/records/483/jcb-laboratories-llc/79a0aa9c-8d44-42b0-94ff-0f3a9d17682d)
- [483 - 2018-09-14](https://www.globalkeysolutions.net/records/483/jcb-laboratories-llc/a31e19bc-0003-4ff8-9a4b-fbead43316d3)

## Related Officers

- [Supervisory Consumer Safety Officer](https://www.globalkeysolutions.net/people/carl-a-huffman/4fa9a65e-2aa5-417c-8369-61edab77c57f)
- [Investigator](https://www.globalkeysolutions.net/people/brett-r-havranek/6a4eaba0-a8df-40f6-a21d-45ec5a0e9f6b)

Company: https://www.globalkeysolutions.net/companies/jcb-laboratories-llc/6a0fb3f5-201a-4d06-bb1b-33f9cc15f7d1

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79