# FDA 483 - Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy - February 27, 2018

Source: https://www.keypedia.com/records/483/lynnfield-drug-inc-dba-freedom-fertility-pharmacy/7c4d2422-0a81-4fbe-be85-9c02b98d145e

> FDA 483 for Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy on February 27, 2018. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy
- Inspection Date: 2018-02-27
- Product Type: Drugs
- Office Name: New England District Office
- Summary: On February 27, 2018, the FDA issued a Form 483 to Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy, a producer of non-sterile and sterile products located at 12 Kent Way, Suite 120F, Byfield, MA 01922-1221. The inspection, conducted from February 6-27, 2018, by Investigator John P. Mistler, identified two observations.

Observation 1 noted that disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile. Specifically, non-sterile wipes were used to clean the interior of the ISO-5 classified areas within the sterile cleanroom suite for aseptic drug product production, with no assessment of this practice.

Observation 2 cited inadequate HEPA filter airflow over areas exposed to sterile product. An air pattern analysis (smoke study) performed on April 12, 2017, for the sterile cleanroom suite and ISO-5 classified areas was deemed inadequate due to faint and intermittent smoke. The ISO-5 areas were not certified under dynamic conditions, and unidirectional airflow was not verified under operational conditions. The smoke studies also failed to include the transfer of starting components, materials, in-process products, or final product into the ISO-5 classified areas.

## Related Documents

- [STATE_REFERRAL_LETTER - 2018-02-16](https://www.keypedia.com/records/state_referral_letter/lynnfield-drug-inc-dba-freedom-fertility-pharmacy/58b16e3b-de65-48f0-8aeb-29200694179a)
- [145 - 2018-09-26](https://www.keypedia.com/records/145/lynnfield-drug-inc-dba-freedom-fertility-pharmacy/732742e0-3269-492e-8a70-4417dc71ce15)

## Related Officers

- [Arizona Market President](https://www.keypedia.com/people/john-p-mistler/7b2d423d-46cc-48bd-aa5a-4ae794888060)

Company: https://www.keypedia.com/companies/lynnfield-drug-inc-dba-freedom-fertility-pharmacy/54dc295d-910f-4ae0-9fb5-f5ebe3b18012

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144