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

Source: https://www.keypedia.com/records/483/morton-drug-company-dba-morton-ltc/92917c15-b859-41a7-bf94-5063f71cbc5a

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

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## 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: On August 27-31, 2018, the FDA inspected Morton Drug Company dba Morton LTC, a producer of sterile and non-sterile products located at 201 E Bell St, Neenah, WI. The inspection, led by Investigators Sandra A Hughes and Tenzin Jangchup, resulted in three observations.

Observation 1 noted inadequate cleaning of work surfaces to prevent cross-contamination for beta-lactam drugs. Specifically, beta-lactam antibiotics were aseptically processed in the ISO 5 area within the past three months, but the cleaning procedure lacked appropriate cleaning agents to mitigate cross-contamination risks.

Observation 2 identified that materials and supplies were not adequately disinfected before entering aseptic processing areas. On August 27, 2018, an operator was observed wiping supplies in the ISO 8 area with a solution and transferring them directly into the ISO 5 aseptic processing area without further disinfection. These supplies were used for aseptic processing of daptomycin 425 mg in 100 mL of 0.9% NaCl.

Observation 3 stated that media fills did not closely simulate aseptic production operations or incorporate worst-case activities and conditions to challenge aseptic operations. The firm's media fill practice involved injecting a substance other than a microbiological growth medium in place of the product.

## Related Documents

- [483 - 2015-12-22](https://www.keypedia.com/records/483/morton-drug-company-dba-morton-ltc/62ff64ec-3d1e-4ba4-9773-f9d41b0c5b96)
- [483 - 2018-08-31](https://www.keypedia.com/records/483/morton-drug-company-dba-morton-ltc/ab3db089-b2cc-4412-9058-533dab2e4da9)
- [STATE_REFERRAL_LETTER - 2018-08-29](https://www.keypedia.com/records/state_referral_letter/morton-drug-company-dba-morton-ltc/52d7734d-7710-42f8-bea7-6657061292db)

## Related Officers

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

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

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