# FDA 483 - Morton Drug Company dba Morton LTC - August 31, 2018

Source: https://www.globalkeysolutions.net/records/483/morton-drug-company-dba-morton-ltc/ab3db089-b2cc-4412-9058-533dab2e4da9

> FDA 483 for Morton Drug Company dba Morton LTC on August 31, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Morton Drug Company dba Morton LTC
- Inspection Date: 2018-08-31
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Morton Drug Company dba Morton LTC in Neenah, WI, was inspected from August 27-31, 2018, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate cleaning procedures for beta-lactam drugs, insufficient disinfection of materials entering aseptic areas, and media fills that did not accurately simulate production operations. These issues indicate potential risks of product contamination and compromise of sterility.

## Related Documents

- [483 - 2015-12-22](https://www.globalkeysolutions.net/records/483/morton-drug-company-dba-morton-ltc/62ff64ec-3d1e-4ba4-9773-f9d41b0c5b96)
- [483 - 2018-08-31](https://www.globalkeysolutions.net/records/483/morton-drug-company-dba-morton-ltc/92917c15-b859-41a7-bf94-5063f71cbc5a)
- [STATE_REFERRAL_LETTER - 2018-08-29](https://www.globalkeysolutions.net/records/state_referral_letter/morton-drug-company-dba-morton-ltc/52d7734d-7710-42f8-bea7-6657061292db)

## Related Officers

- [Performance Improvement Coordinator](https://www.globalkeysolutions.net/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Sandra A. Hughes](https://www.globalkeysolutions.net/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.globalkeysolutions.net/companies/morton-drug-company-dba-morton-ltc/4822f40d-59ca-4240-a80e-6050b088c619

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d