# FDA 483 - good health, inc.  - November 29, 2018

Source: https://www.keypedia.com/records/483/good-health-inc/f30004f7-3215-419a-959b-935aff0c0745

> FDA 483 for good health, inc.  on November 29, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: good health, inc. 
- Inspection Date: 2018-11-29
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: This FDA Form 483 documents observations from an inspection of a facility producing beta-lactam drug products. The primary concern is inadequate cleaning of work surfaces, leading to potential cross-contamination.

The facility produces penicillin-containing drug products in the same ISO Class 5 environment as non-penicillin beta-lactam drug products. The cleaning procedure between batches involves only the use of Sterile (b)(4). There are (b)(4) ISO Class 5 hoods located within an ISO Class 7 buffer room used for sterile drug production.

A critical finding is the lack of assurance that the current cleaning process within the hoods prevents cross-contamination between penicillin and non-penicillin beta-lactam drug products. Specifically, on November 9, 2018, production in Hood #E28777 included Ertapenem 500mg/100mL NS, followed by Vancomycin HCl 850mg, and then Penicillin G Potassium, 3MU/D5W 50mL. Between these products, only a cleaning utilizing (b)(4) was performed. The document notes that no cleaning agent is used between products to effectively break down penicillin activity or the beta-lactam ring. This indicates a significant deficiency in the firm's quality system regarding cleaning validation and cross-contamination control for potent and allergenic compounds.

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Company: https://www.keypedia.com/companies/good-health-inc/7e17d544-d7ee-4335-8255-48f407dc74b4

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