# FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - November 05, 2020

Source: https://www.keypedia.com/records/483/novel-laboratories-inc-dba-lupin-somerset/5b4aee89-c5fd-487d-89cc-dbac6cbe518e

> FDA 483 for Novel Laboratories, Inc. d.b.a Lupin Somerset on November 05, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novel Laboratories, Inc. d.b.a Lupin Somerset
- Inspection Date: 2020-11-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details observations from an inspection, primarily focusing on deficiencies in equipment cleaning, maintenance, and quality unit investigations.

**Facility and Operation Details:** The inspection covered various buildings and equipment used for manufacturing multiple drug products, including Tinidazole Tablets, Trimethoprim Tablets, Voriconazole Tablets, Hydrocodone Bitartrate/Homatropine Methylbromide Tablets, Phenelzine Sulfate Tablets, Methylergonovine Maleate Tablets, Temazepam Capsules, Trimethobenzamide HCl Capsules, Potassium Chloride Oral Solution, Hydrocodone/Acetaminophen Tablets, GaviLyte N (Lemon), and Flucytosine Capsules. Non-dedicated equipment is frequently utilized for different products.

**Violations and Observations:**

**Observation 1: Equipment and Utensils Cleaning and Maintenance Deficiencies**
*   **Contaminated "Cleaned" Equipment:** Numerous instances of equipment labeled "cleaned" were found with powder residue, visible damage, dirt, rust-like material, or water-like liquid. Examples include a blender (Equipment #0235) with unknown white powder and visible damage, a used drum without unique ID containing black mold-like appearance and powder residue, trays (Equipment #0351, #0352) with white powder residue, a capsule filling machine (Equipment #0247) with powder residue and rust-like material, a liquid processing equipment (Equipment #0837) with residual

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## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)

Company: https://www.keypedia.com/companies/novel-laboratories-inc-dba-lupin-somerset/53a42119-c077-49fb-b739-db29c2b99391

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