# FDA EIR - BMC 1092, Inc. - September 28, 2016

Source: https://www.keypedia.com/records/eir/bmc-1092-inc/96d85acb-16fc-4eae-b6be-14dabc8e7b6d

> FDA EIR for BMC 1092, Inc. on September 28, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: BMC 1092, Inc.
- Inspection Date: 2016-09-28
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of BMC 1092, Inc. dba Solo Laboratories, Inc., an OTC topical drug and cosmetic contract manufacturer in Broadview, IL, was conducted from September 14 to September 28, 2016. This inspection, carried out under drug manufacturing and cosmetic compliance programs, revealed significant issues across multiple systems. The firm received an FDA-483 with three primary observations. The first concerned deficient procedures for preventing objectionable microorganisms in non-sterile drug products, including 18 instances of purified water exceeding microbial limits without investigation, inadequate testing and documentation of water system points of use, lack of documented contact time during water system sanitization, and an uncontrolled, unidentified point of use with improper drainage. Secondly, the company's stability program for drug products was found lacking reliable and specific test methods, notably failing to include microbiological testing for several OTC drug products like sunscreen and antiperspirant. Finally, change control procedures were inadequate, not covering changes to facilities, equipment, materials handling, or production systems, and lacking requirements for prospective review, evaluation criteria, or effectiveness assessments. The regulatory framework guiding this inspection involved the Food, Drug, and Cosmetics Act, specifically 21 CFR parts related to microbiological controls, stability testing, and production/process controls. Management committed to addressing the observations and submitting a written response to the FDA within 15 business days, outlining corrective actions.

## Related Documents

- [EIR - 2016-09-28](https://www.keypedia.com/records/eir/bmc-1092-inc/f98d67e1-6ae7-49b1-b512-cee7bb37979e)

## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [company_representative](https://www.keypedia.com/people/yolanda-alfaro/b1aa2529-9fbe-4115-9673-6af8ab2cbb1c)
- [recipient](https://www.keypedia.com/people/brian-d-corcoran/b4c87471-aa8b-4be6-9166-3ea3d3cd4910)
- [company_representative](https://www.keypedia.com/people/adelisa-a-patel/ba49f43a-1920-475e-8a2f-6b415c9068b1)

Company: https://www.keypedia.com/companies/bmc-1092-inc/beffba4b-ce73-4f63-967f-058e31d58634

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669